Table 1.

Study characteristics

Characteristic	ARO 96-02	EORTC 22911	SWOG 8794	FP-FINROG-0301
Sample size (n)	307	1005	425	250
Median followup (years)	aRT: 9.3 Obs: 9.4	10.6	12.6	aRT: 9.3 Obs: 8.6
Key inclusion and exclusion criteria	Inclusion: – Histological PCa – No distant metastases pT3–4 pN0 – + or – surgical margins – <76 yrs of age – WHO performance status of 0 or 1 Exclusion: – Detectable postop PSA	Inclusion: – ≤ 75 yrs of age – WHO performance status of 0 or 1 Histological PCa – cT0–3N0M0 – pT2–3N0, – ≥ 1: capsular perforation, PSM, or SVI	Inclusion: – cT1–2 PCa – RP within 16 weeks prior to randomization – ≥ 1: extracapsular tumor extension, PSM, or SVI – Negative bone scan – Performance status of 0–2 – No evidence of urinary incontinence, infection, or urinary extravasation – No history of intraoperative rectal injury – No prior RT or chemotherapy for PCa	Inclusion: – pT2N0M0 with a PSM or pT3aN0M0 PCa Exclusion: – Other concurrent cancer therapy, including systemic endocrine therapy – 12 wks since RP – Metastatic disease (N+ or M1) – SVI
Detectable postoperative PSA	0%	29.9%	29.9%	aRT: 70% PSA <0.2–0.5 Obs: 65% PSA <0.2–0.5
Radiation type and dose	3- or 4-field technique; 60 Gy in 30 fractions	2D radiation; 60 Gy in 30 fractions	2D radiation; 60–64 Gy in 30–32 fractions	3D-conformal RT; no nodal radiation; 66.6 Gy in 37 fractions
Primary outcome	bPFS	bPFS	MFS	bPFS
Secondary outcomes	MFS, OS	Local control, salvage XRT, MFS	PFS, PSA relapse-free interval	OS, CSS, adverse events
Rate of salvage XRT among patients with BCR in the control arm	NR	43.4%	33.2%	86%
Median PSA at time of salvage XRT (μg/l)	NR	1.7	0.75–1.0	0.7
Biochemical PFS	10-year estimate: aRT: 56.0% Obs: 35.0%	10-year: aRT: 61.6% Obs: 41.1%	Median followup: aRT: 60.7% Obs: 47.4%	10-year estimate: aRT: 82% Obs: 61%
Local RFS	NR	10-year: aRT: 83.4% Obs: 92.7%	NR	NR
MFS	Median followup: aRT: 84.3% Obs: 85.1%	10-year: aRT: 89.9% Obs: 89.0%	Median followup: aRT: 56.5% Obs: 46%	10-year estimate: aRT: 98% Obs: 96%
CSS	NR	10-year: aRT: 96.1% Obs: 94.6%	NR	10-year estimate: aRT: 99% Obs: 99%
OS	Median followup: aRT: 86.5% Obs: 85.5%	10-year:<:br>aRT: 76.9% Obs: 80.7%	Median followup: aRT: 74.0% Obs: 66.0%	10-year estimate:<:br>aRT: 92% Obs: 87%
Overall adverse event rates	Median followup: aRT: 21.9% Obs: 3.7%	10-year: aRT: 70.8% Obs: 59.7%	Median followup*: aRT: 23.8% Obs: 11.9%	NR**
Grade 3+ adverse event rates	Median followup: aRT: 1% Obs: 0%	10-year: aRT: 5.3% Obs: 2.5%	NR	Median followup: aRT: 57% Obs: 40%

^*10.6 years;

^**not reported in a cumulative fashion.

aRT: adjuvant radiation therapy; BCR: biochemical recurrence; bPFS: biochemical progression-free survival; CSS: cancer-specific survival; LRFS: local recurrence-free survival; MFS: metastasis-free survival; NR: not reported; Obs: observation; OS: overall survival; PCa: prostate cancer; PSM: positive surgical margins; RP: radical prostatectomy; RT: radiation therapy; SVI: seminal vesicle invasion; WHO: World Health Organization; XRT: radiation therapy.